Sex differences in non-small cell lung cancer (NSCLC) outcomes have been described. Immune-related adverse events (IRAEs) have emerged as a serious clinical problem in the use of immune checkpoint inhibitors (ICI). Risk factors for IRAEs and their association with response to therapy remain controversial. Therefore, we studied sex differences in IRAEs and their association with response to therapy.

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Method

All patients with metastatic NSCLC treated with anti-PD1 and anti-PDL1 therapy at Mayo Clinic Rochester and Florida from 2015 to 2018 were reviewed. Patients receiving treatment at an outside facility or with history autoimmune disorders were excluded. Kaplan-Meier method was used for time-to-event analysis.

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Result

231 patients were identified, 120 (52%) were women and 111 (48%) were men. Baseline characteristics and ICI distribution were similar among groups (Table 1). Women were more likely to experience IRAEs compared to men (48% vs. 31%, p<0.008). Among patients with IRAEs, women were more likely to be prescribed systemic steroids (63% vs. 41%, p<0.02). Women were more likely to develop pneumonitis (23% vs. 12%, p<0.03) and arthralgia (17% vs. 3%, p<0.04). However, dermatologic toxicities (35% vs. 9%, p<0.002) were more commonly seen in men. In 17% of women the ICI was discontinued due to toxicity (men 7%). Besides sex, no other clinical characteristic was associated with increased IRAEs. Women with IRAEs were more likely to have a radiographic response compared with women without IRAEs (78% vs. 23%, p<0.0001), although this was not observed in men (37% vs. 26%, p>0.22). Better PFS was observed in women with IRAEs (10 months vs. 3.3 months, p<0.0006) compared to women without IRAEs.

Women % (n)

Men % (n)

p value

PD-L1 expression ≥1%

30 (36)

34 (38)

0.29

Adenocarcinoma

77 (92)

66 (73)

0.02

Bone metastasis

34 (41)

47 (52)

0.05

Brain metastasis

20 (24)

22 (24)

0.76

Liver metastasis

13 (15)

10 (11)

0.53

Prior chemotherapy

74 (89)

85 (94)

0.06

Prior palliative radiation

53 (63)

57 (63)

0.52

IRAEs

48 (57)

31 (34)

0.006

≥3 grade IRAEs

42 (24)

29 (10)

0.22

Received systemic steroids

63 (36)

41 (14)

0.02

Required intravenous steroids

30 (17)

24 (8)

0.47

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Conclusion

Women with metastatic NSCLC are more likely to experience IRAEs compared to men. In women, an association between IRAEs and response to therapy was observed. Larger studies are needed to investigate the mechanisms underlying these associations.

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